Status:
WITHDRAWN
US/MRI Fusion Local Anestesia TransPerineal Prostate Biopsies for Detection of Prostate Cancer
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Capio Sankt Görans Hospital
GHP Urologi Odenplan
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
We are conducting a randomised trial comparing outcomes of transperineal prostate biopsies under free-hand software assisted MRI/US fusion with transrectal biopsy guide software assisted MRI/US fusion...
Detailed Description
Prostate cancer is a leading cause of cancer death among men in the Western world. Early detection of prostate cancer has been shown to decrease mortality. When a test for prostate cancer yields an el...
Eligibility Criteria
Inclusion
- Signed written informed consent to participate
- Be aged 18 years and over
- An understanding of the Swedish language sufficient to understand written and verbal information about the trial and consent process
- Be suited and fit for either procedure (transrectal/transperineal)
- Be suitable for a prostate biopsy and clinically due to have a biopsy for diagnostic purpose (following indications for biopsy)
- Biopsy naïve
- Men on active surveillance (AS)
- Rebiopsy
- Be willing and able to comply with scheduled visits and completion of study questionnaires
Exclusion
- Severe illness such as metastatic cancers, sever cardio-vascular disease or dementia
- Men with contraindication for a prostate biopsy
- Men without suspect lesions on MRI
- Previous TURP or other BPH treatment (HoLEP, PostaLUND, water-vaporization) is permitted, but men who have had HIFU, cryo, IRE (irreversible electroporation), photodynamic, or microwave therapy to the prostate will not be included.
- Previous treatment with BCG for bladder cancer
- Men who are unable to undergo transrectal ultrasonography
- Men who have had previous radiation therapy to the pelvis
- Men not tolerating ciprofloxacin
- Unable to lie down with legs in a stirrup for at least 45 minutes, as assessed by a clinician
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04797078
Start Date
April 1 2023
End Date
November 15 2025
Last Update
March 10 2023
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